FDA stinks at policing conflicts

Just when you thought nobody could be worse than the National Institutes of Health at managing financial conflicts of interest among trial investigators... The Inspector General of the Department of Health and Human Services released a linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf today that indicates a pretty severe lack of oversight over at the Food and Drug Administration. The report found that only one percent of the almost 27,000 clinical investigators contracted by

Bob Grant
Bob Grant

Bob started with The Scientist as a staff writer in 2007. Before joining the team, he worked as a reporter at Audubon and earned a master’s degree in science journalism...

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Jan 11, 2009
Just when you thought nobody could be worse than the National Institutes of Health at managing financial conflicts of interest among trial investigators... The Inspector General of the Department of Health and Human Services released a linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf today that indicates a pretty severe lack of oversight over at the Food and Drug Administration. The report found that only one percent of the almost 27,000 clinical investigators contracted by the agency in 2007 disclosed a financial interest. In 42% of clinical trials, the FDA never even received the financial disclosure forms from participating investigators that the agency mandates. The FDA not only failed to address these shortcomings, in 20% of the trials where investigators did report a financial conflict, the FDA took no action. In 31% of trials where researchers did submit financial conflict documentation, FDA reviewers didn't even indicate that they read the forms. If this isn't enough to make...
rs... The Inspector General of the Department of Health and Human Services released a linkurl:report;http://www.oig.hhs.gov/oei/reports/oei-05-07-00730.pdf today that indicates a pretty severe lack of oversight over at the Food and Drug Administration. The report found that only one percent of the almost 27,000 clinical investigators contracted by the agency in 2007 disclosed a financial interest. In 42% of clinical trials, the FDA never even received the financial disclosure forms from participating investigators that the agency mandates. The FDA not only failed to address these shortcomings, in 20% of the trials where investigators did report a financial conflict, the FDA took no action. In 31% of trials where researchers did submit financial conflict documentation, FDA reviewers didn't even indicate that they read the forms. If this isn't enough to make you smack your forehead and send your morning coffee spraying from one nostril, the FDA also apparently told the inspector general that it wasn't that interested in requiring drug makers to collect and report accurate financial disclosure information from investigators prior to the commencement of clinical trials. "FDA asserted that this additional effort would not be worthwhile because financial interests are only one form of potential bias," the report reads. All of this doesn't appear to be bothering potential clinical trial participants searching to wring a buck out of our foundering economy, though. The __Boston Globe__ linkurl:reported;http://www.boston.com/news/world/europe/articles/2009/01/05/paid_studies_draw_more_interest_in_sour_economy/?page=1 last week that the number of Americans seeking to become paid clinical trial subjects has skyrocketed since the economy went south.
**__Related stories:__***linkurl:Should conflicts mean no NIH grant?;http://www.the-scientist.com/blog/display/55058/
[29th September 2008]*linkurl:Report faults NIH on conflicts;http://www.the-scientist.com/blog/display/54183/
[18th January 2008]*linkurl:CSPI: FDA can manage conflicts better;http://www.the-scientist.com/blog/display/53953/
[3rd December 2007]

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